---
type: "WebPage"
title: "Chemical analysis and characterization services for implantable medical devices according to ISO 10993-18"
description: "Implantable Medical Device: what are we talking about? An implantable device is an invasive device intended to remain in the patient’s body: for example, catheters, orthopedic implants, joint prostheses, dental implants…Class 3 devices are highly critical and require significant quality..."
resource: "https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/implant-biocompatibility-iso-10993-18/"
tags: ["EN", "pll_617170347d612", "Anaïs DECAUX"]
timestamp: "2026-08-25T05:51:15Z"
published: "2021-10-21T14:01:38Z"
language: "en"
author: "Laure Durieux"
---

# Chemical analysis and characterization services for implantable medical devices according to ISO 10993-18

## Implantable Medical Device: what are we talking about?

An implantable device is an invasive device intended to remain in the patient’s body: for example, catheters, orthopedic implants, joint prostheses, dental implants…

Class 3 devices are highly critical and require significant quality procedures in order to obtain marketing authorization.

## The FILAB laboratory supports you in the chemical characterization of your implants according to ISO 10993-18

The biocompatibility assessment of a medical device is carried out in accordance with ISO 10993-1, which refers to ISO 10993-18 for the physico-chemical analysis of the materials used. This step makes it possible, among other things, to:

- Gain a better understanding of the material used in your production process, whether metallic, polymer, or ceramic materials
- Assess the leaching of chemical substances from medical devices
- Measure the equivalence of materials used in medical devices, including in the context of dual or multi-sourcing

This step is particularly essential [for implantable medical devices](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-material-chemical-characterization.md).

**COFRAC 17025 accredited** for these analyses, FILAB laboratory offers you a complete service to support your characterization efforts in line with the requirements of ISO 10993-18:

- [AET calculation](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/medical-devices-calculation-aet.md)
- [Validation of extraction completeness according to ISO 10993-12](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-exhaustiveness-verification-iso-10993-12.md)
- Identification and quantification of organic residues by HS/GC-MS, GC-MS, LC-MSMS…
- Identification and quantification of inorganic residues by ICP-MS, ICP-AES, CLI…

For all types of materials (polymer, metal, ceramic) and implantable devices.

Examples of work:

- Physico-chemical characterization of an implantable textile
- Physico-chemical characterization of a catheter in [silicone](https://filab.fr/en/our-services/our-analysis-services/polymer-materials-analysis-laboratory/laboratory-analysis-silicone.md)
- Physico-chemical characterization of dental implants in TA6V
- Physico-chemical characterization of a metallic implantable prosthesis

FILAB also supports you with the following services:

- Study of [Biocompatibility according to ISO 10993](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing.md) (-[18](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-material-chemical-characterization.md) / –[12](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-exhaustiveness-verification-iso-10993-12.md) / –[13](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/iso-10993-13-medical-devices-characterization.md) / –[14](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/identification-and-quantification-of-degradation-products-on-ceramic-medical-devices-according-to-iso-10993-14.md) / -15 / -19 / –[22](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-nanomaterial/laboratoty-iso-10993-22-nanomaterial-characterization.md))
- [R&D support](https://filab.fr/en/our-services/rd.md): [Custom chemical analysis](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-biomedicine.md), [materials and surface characterization](https://filab.fr/en/our-services/our-analysis-services/laboratory-material-testing.md), [analytical development](https://filab.fr/en/our-services/our-expertise-services/analytical-development.md)
- [Problem solving](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-failures.md): non-conformity, [failure](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-failures/laboratory-analysis-ruptures.md), [adhesion](https://filab.fr/paroles-d-expert/metallurgie-fonderie-automobile/filab-vous-accompagne-dans-les-problematiques-d-adhesion.md), [corrosion](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-deposit-contamination/laboratory-expertise-and-analysis-of-corrosion.md)…
- Process validation: [Cleaning](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227.md) (ISO 19227), [surface treatment](https://filab.fr/en/our-services/our-analysis-services/laboratory-surface-characterization/laboratory-analysis-expertise-surface-treatment.md)